Wrong-Site Surgery Rare but Not Entirely Preventable

Action Points

Advise patients who ask that this study shows that wrong-site surgery is extremely rare, and although shocking to the public serious injury is even rarer.

Note that protocols to prevent such incidents have been established, but are not foolproof and are unlikely to prevent every single case.

BOSTON, April 17 - Current protocols to avoid wrong-site surgery would prevent only about six in 10 cases, according to a 20-year review of these botched procedures reported to a large malpractice insurer.

Yet wrong-site surgery is extremely rare and major injury even rarer, reported Mary Kwaan, M.D., of Brigham and Women's Hospital and the Harvard School of Public Health here in the April issue of Archives of Surgery.

Dr Kwaan and colleagues found that fewer than one in 112,000 non-spine operations could be classified as wrong-site surgery.

"Wrong-site surgery is rare but shocking to the public," the researchers concluded. However, "at the rate detected in this study, a wrong-site surgery serious enough to result in a report to risk managers or a lawsuit would occur at a single large hospital about once every five to 10 years."

That said, they noted, publicity surrounding such cases causes public alarm and has led the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to develop a protocol that all accredited hospitals must now implement. The minimum requirements of the protocol are preoperative verification of both the surgical site and the patient, marking the surgical site on the patient, and the institution of a "time out" in the operating room for final confirmation.

But it's not clear how effective such protocols can be, the researchers said, especially since there is significant variation among hospitals.

Wrong-site surgery, Dr. Kwaan and colleagues said, includes procedures on the wrong person, organ or limb, or the wrong vertebral level, in the case of spinal surgery. The researchers did not include spinal surgery in this study because verification of vertebral level involves an intra-operative radiological marking process, which differs from the pre-operative verification and marking process used in non- spine procedures.

As part of a larger study of medical error among malpractice claims, the researchers looked at records between 1985 and 2004 of Controlled Risk Insurance Corp., which provides liability insurance to a third of Massachusetts physicians and about 30 hospitals.

They found 40 cases of wrong-site surgery, of which 25 (or 62%) were non-spinal.

However, during the study period, the hospitals performed 1,426,901 inpatient and 1,399,466 outpatient surgical procedures, yielding an estimated incidence rate of one in 112,994 operations for non-spinal wrong-site surgery. The 95% confidence interval ranged from one in 76,336 cases to one in 174,825.

Of the 25 cases, medical records were available for review in 13, the researchers found; only one of the cases had results regarded as both permanent and significant, while the remainder were temporary and ranged from slight scarring to a moderately or severely delayed recovery.

Nine cases involved ambiguity or error that preceded the arrival of the patient at the operating room and four could be been prevented by review of radiological films or reports, although in two cases, the radiological findings were not available in the operating room.

The JCAHO protocol would not have prevented five of the cases (or 38%) but "under optimal conditions" it might have prevented the other eight, the researchers said. Specifically:

In two cases, a clear contradiction might have been detected between the site described on the consent form and the site described on the operating room schedule.

In another case, discussion with the patient might have revealed an error in the operating room schedule.

In two cases, a requirement to specify the site of the procedure on the consent form and the operating room schedule would likely have prevented wrong-side hip surgery and umbilical instead of epigastric hernia repair.

In another case, specifying the side on a radiological report would likely have prevented wrong-site surgery.

Two cases might have been prevented by site marking. In a wrong-toe case, the correct foot was marked, but the toe intended for surgery was not. In another case, site marking might have prevented the surgeon from making a herniorrhaphy incision on the opposite side of the defect.

The study showed that "although site-verification protocols offer some protection against such errors, they are not foolproof," said Carolyn Clancy, M.D., director of the Agency for Healthcare Research and Quality, which supported the study, in a statement. "We have a lot more to do to ensure that wrong-site surgery never happens."

Indeed, the researchers concluded that "no protocol will prevent all cases" and argued that the responsibility for preventing wrong-site surgery lies ultimately on the shoulders of the surgeon.

The study may understate wrong-site surgery, Dr. Kwaan and colleagues said, because it only includes mistakes serious enough to prompt malpractice claims or reports to the insurer. Also, it's not clear how the state of affairs changed over the 20-year period, and specifically after site-specification protocols were introduced.

Reviewed by Zalman S. Agus, MD Emeritus Professor at the University of Pennsylvania School of Medicine

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